Quality Assurance Manager Cmos
Posted on Feb. 25, 2026 by Recordati S.p.A
- Malazgirt, Italy
- N/A
- Full Time
Quality Assurance Manager CMOs
ID: 2323
Date of Posting: Feb 24, 2026
Business Area: Quality
Job Type: Direct Employee
On site / Remote / Hybrid: On Site
Hub Office:
Nanterre, FR
Territory:
Full-Time or Part-Time: Full Time
Seniority: Executive
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.
Job Purpose
The CMO Quality Assurance Manager is responsible for ensuring robust quality oversight of all Contract Manufacturing Organizations (CMOs) engaged by Recordati Rare Diseases.
The role ensures that outsourced manufacturing activities are conducted in full compliance with applicable Good Manufacturing Practices (GMP) and relevant national and international regulatory requirements.
By supervising and supporting quality assurance activities related to Contract Manufacturing Organizations (CMOs), this position contributes to maintain the highest standards of product quality, regulatory compliance, and patient safety.
This position is open as part of a maternity leave replacement.
Key Responsibilities
QA Operations & CMO Oversight
- Ensure quality oversight of all CMO activities (manufacturing, packaging, testing).
- Implement governance processes and KPIs to monitor CMO performance.
- Ensure compliance with US FDA cGMP, EU-GMP, and internal quality standards.
- Conduct audits and inspections of CMOs and ensure follow‑up on findings.
- Develop, review, and maintain Quality Agreements with CMOs.
- Ensure proper documentation for all quality activities (batch records, validation, audits).
- Identify quality risks and implement mitigation actions.
- Provide training and guidance on quality standards to CMO teams.
- Drive continuous improvement of quality systems at CMOs.
- Work closely with internal teams (Regulatory Affairs, Supply Chain, Manufacturing).
- Manage change controls related to CMOs.
- Oversee Annual Product Quality Reviews (APQR) with CMOs.
- Participate in routine governance meetings and provide KPI reporting.
- Contribute to CMO evaluation and qualification.
QA Support to Projects
- Support industrial technology transfer projects as the QA representative when required
Audits & Inspections
- Participate in internal and external audits to assess GMP compliance.
- Communicate audit findings and support development of CAPAs.
- Maintain audit plans and ensure timely completion of corrective actions.
- Support preparation and management of regulatory inspections related to external manufacturing.
Optional QA Operations Support (When required)
- Certify batches produced by CMOs.
- Review and approve deviations, CAPAs, and change controls.
- Follow up on CAPA closure with CMOs.
Required Education
- Bachelor’s degree in Pharmacy from a recognized institution in France.
- Licensed French Pharmacist (mandatory).
Required Skills and Experience
- Minimum 5 years of QA experience in the pharmaceutical industry, including CMO oversight
- Strong knowledge of US FDA cGMP and EU‑GMP regulations
- Solid analytical, problem‑solving, and communication skills
- Ability to work independently and collaboratively.
- Good understanding of pharmaceutical industry regulations and constraints
- Demonstrated leadership in a multicultural environment
- High autonomy in daily activitie
- QA certifications (e.g., ASQ CQA, CQM) are an advantage.
Technical Competencies
- Minimum 5 years of experience in pharmaceutical Quality Assurance, including oversight of CMOs.
- Strong knowledge of US FDA cGMP and EU‑GMP regulations.
- Solid analytical, problem‑solving, and communication abilities.
- Proven capacity to work independently as well as collaboratively.
- Fluent French & English, written and spoken.
- Very good understanding of pharmaceutical regulations, industry standards, and operational constraints.
- Demonstrated leadership in multicultural environments.
- High level of autonomy in daily activities.
- Willingness to travel, including overnight stays.Relevant QA certifications (e.g., ASQ CQA, CQM) are a plus.
Required Behaviours and Competencies
- Leadership: Able to guide, influence, and collaborate effectively with colleagues at all levels in a multicultural environment.
- Autonomy: Works independently, manages priorities, and makes sound decisions with minimal supervision.
- Effective Communication: Conveys information clearly, adapts communication style to diverse audiences, and fosters open collaboration.
- Problem-Solving Mindset: Approaches issues analytically and proposes practical, efficient solutions.
- Team Orientation: Works constructively within cross‑functional teams and maintains strong relationships with internal and external partners.
- Adaptability: Comfortable operating in a dynamic environment and adjusting to evolving regulatory or operational demands.
- Accountability: Takes ownership of tasks, follows through on commitments, and ensures high‑quality outcomes.
- Continuous Improvement: Demonstrates a proactive approach to enhancing processes, systems, and ways of working.
- Professionalism & Integrity: Acts with reliability, transparency, and respect for ethical and regulatory standards.
- Commitment to Quality: Maintains a strong focus on compliance, accuracy, and patient safety in all activities.
Required Languages
French and English are mandatory (written and spoken), very good level to work in an international environment.
Travel required in %
Approx. 10% of travel in a year (Europe).
At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
Advertised until:
March 27, 2026
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